Clinical Trials

Subconjunctival Humira for Boston Keratoprosthesis

Study Purpose

This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age 18 years or older.

- Individuals eligible for keratoprosthesis surgery, as determined by standard-of-care eligibility criteria.

- Patients with poor prognosis for corneal transplantation, severe corneal opacity and/or vascularization.

- Patients with vision worse than 20/200 in the eligible eye, and contralateral eye with vision less than 20/40.

- Patients with intact nasal light projection.

- Willing and able to comply with study plan for the full duration of the study.

- Willing and able to sign a written informed consent.

Exclusion Criteria:

- Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-# release assay [IGRA] test, such as Quantiferon-gold) - Untreated active hepatitis B or C infection.

- Ocular or periocular malignancy and/or infection.

- Inability to wear contact lens.

- Pregnancy (positive pregnancy test) or lactating.

- Participation in another interventional study at the time of screening.

- Any of the following baseline lab values.

1. White blood count <3500 cells per microliter. 2. Platelets <100,000 per microliter. 3. Hematocrit <30% 4. AST or ALT >1.5X upper limit normal value.

- Multiple sclerosis or other demyelinating disease.

- Severe uncontrolled infection.

- Moderate to severe heart failure (NYHA class III/IV) - Active malignancy.

- History of adalimumab intolerance.

- Pregnancy or lactation.

- Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures.

- As judged by the investigator any patients that are questionable for their suitability in the study

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06926478
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Massachusetts Eye and Ear Infirmary
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Thomas Dohlman, MD
Principal Investigator Affiliation	Massachusetts Eye and Ear
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Penetrating Keratoplasty, Multiple Graft Failure, Ocular Cicatricial Pemphigoid, Stevens-Johnson Syndrome

Additional Details

This is a Phase I, Open-label, IND trial for participants undergoing a Boston Keratoprosthesis (KPro) procedure, to receive an injection of adalimumab (Humira), to study the safety and tolerability as well, to study whether there is a decrease to post surgical complications, and symptoms that participants would experience, if they did not receive the injection. The study will recruit eight

(8) participants, who will be monitored for thirty (30) days after the surgery, through eye examination and eye photos.

Arms & Interventions

Arms

Experimental: Adalimumab (Humira)

This arm will receive the study intervention.

Interventions

Drug: - Adalimumab Injection

10% (4.0mg/0.04ml) dissolved in sterile saline to be injected once during the time of the Boston Keratoprosthesis (Kpro) Surgery.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts Eye and Ear, Boston, Massachusetts

Status

Address

Massachusetts Eye and Ear

Boston, Massachusetts, 02114

Site Contact

Michael Cheung, MSc, CCRP

[email protected]

617-573-6060

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